# K201104: AsoAligner

- Pathway: 510(k) (Traditional)
- Applicant: Aso International Manila, Inc.
- Decided: Feb 26, 2021 after 308 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K780619 (1978). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143499: eCligner, Eclear International Co., Ltd. (2015) Summary page 4.

## Indications for use
AsoAlignerTM is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). AsoAligner™ is intended for minor anterior tooth movement by applying continuously gentle force. AsoAligner™ is for prescription only use.

Source page: https://510kreport.com/device/K201104
Methodology: https://510kreport.com/methodology